The FDA demands rigorous new testing of all imported heparin ingredients and products when it is reported that the Chinese-produced heparin were contaminated.
U.S. Food and Drug Administration officials added that they are near in identifying the contaminant found that causes allergic reactions. They said that when the contaminant is identified, they will be able to know if it is intentionally added or not during manufacturing.
Dr. Janet Woodcock, acting director of the FDA's center for drug evaluation and research, said that they have not yet established a direct connection between the contaminated heparin and the allergic reactions. She said the heparin-like molecule found in the contaminated lots was similar to the drug itself and was not detected until the new refined tests were developed. FDA chemists are "close to nailing down exactly what it is," she said.
Heparin, commonly used in dialysis, is used to prevent blood clots from forming in people who have certain medical conditions or who are undergoing certain medical procedures that increase the chance that clots will form. Heparin is also used to stop the growth of clots that have already formed in the blood vessels, but it cannot be used to decrease the size of clots that have already formed.
The most common reactions are difficulty in breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure. All these can prove fatal and thus further analysis was done on the effect of this drug.
